Electromechanical Drive and Remote Surgical Instrument Attachment Having Computer Assisted Control Capabilities

ABSTRACT

A medical tool comprising an electromechanical driver and a surgical instrument attachment for use in invasive surgery, including a handle coupled to a flexible sheath which is in turn coupled to a surgical attachment. The handle of the driver includes the electromechanical driver and at least one processor element which controls the actions of the electromechanical driver, and therefore the application elements of the surgical attachment, based on information relayed between the processor element and remotely activateable sensor assemblies in the surgical instrument attachment.

RELATED APPLICATIONS

This application is a continuation of and claims benefit of priority toApplicant's U.S. patent application Ser. No. 10/761,491, entitled“Electromechanical Driver and Remote Surgical Instrument AttachmentHaving Computer Assisted Control Capabilities”, filed Jan. 20, 2004, andissuing as U.S. Pat. No. 7,077,856, on Jul. 18, 2006, which is adivision of U.S. patent application Ser. No. 09/510,927, filed Feb. 22,2000, now issued as U.S. Pat. No. 6,716,233, the disclosures of whichare hereby fully incorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to a medical tool comprising anelectromechanical driver which transmits information to and receivesinformation from, and thereby controls, a surgical instrumentattachment, and more specifically to the mechanisms employed to providesuch remote direction and information relaying between saidelectromechanical driver and said surgical instrument attachment.

BACKGROUND

It shall be understood at the outset, that the present invention hasmany applications within the field of surgery. This disclosure shallnot, therefore, be read as limiting of the scope of the invention by thespecific medical or surgical applications which may be described herein,as they are only used as elucidating examples of such applications inwhich the present invention may be employed to enhance the outcomesand/or surgical efficiency. In particular, the present disclosure isdirected to embodiments used in colon surgery, and specifically toanastomosing, resecting, and stapling instruments, however, the sameinvention may be applied to other surgical applications in the fields ofgynecological surgery, cardiovascular surgery, and general surgery.

Upon identification of cancerous or other anomalous tissue in thegastrointestinal tract, surgical intervention is often prescribed. Thefield of cancer surgery, and more specifically, the surgical procedureby which a section of the gastrointestinal tract which includescancerous or anomalous tissue is resected, includes a number of uniquelydesigned instruments. In combination with a description of the presentinstrumentation and their functions, a description of the state of theart in this surgical procedure shall also be provided.

The first question which must be answered when determining how to treatgastrointestinal cancer relates to the specific location of thecancerous tissue. This is very important insofar as the instrumentswhich are provided in the present art have limitations relating to howfar they may be inserted into the gastrointestinal tract. If thecancerous tissue is too far up the colon, for example, then the standardinstrumentation provided is unusable, thus requiring specialaccommodations. These accommodations generally increase the risk ofcontamination of the surrounding tissues with bowel contents, increasethe length of the surgery and the corresponding need for anesthesia, andeliminate the benefits of precise anastomosing and stapling which comesfrom utilizing a mechanized device.

More specifically, in the event that the cancerous tissue is located ata position in the colon which is accessible by the presentinstrumentation, the patient's abdomen is initially opened to expose thebowel. The surgeon then utilizes a linear cutter and stapling devicewhich cuts the tube of the colon on either side of the cancerous tissue,thereby creating two stapled ends of the bowel (a distal end which isdirected toward the anus, and the proximal end which is closest to thesmall intestine). This is done in order to temporarily minimizecontamination.

The surgeon then partially opens the proximal end and inserts theremovable anvil portion of an anastomosing and stapling instrument intothe exposed proximal end. This step, as well as those of the remainderof the surgical procedure, are related to the functioning of thissurgical instrument. More particularly, and with respect to FIG. 1, thesurgeon begins by taking the instrument 30 and manually turning the dial32 at the base of the handle 34 which causes the anvil head 36 at theopposite end to advance forward. The surgeon continues to turn the dial32 until the anvil head 36 advances to its most extreme extendedposition. This manual turning requires nearly thirty full rotations.Once fully extended, the anvil head of the instrument is decoupledtherefrom and is inserted into the partial opening of the proximal endsuch that the coupling post extends outwardly therethrough. This partialopening of the proximal end is then sutured closed. The extending shaft38 of the anastomosing and stapling instrument 30 is then inserted andadvanced into the lower colon, transanally, until the coupling stem 40thereof extends through the stapled distal end. The surgeon then joinsthe coupling ends of the anvil and shaft together and begins to manuallyrotate the dial in the handle again, this time bringing the anvil headcloser to the end 42 of the shaft.

Once the anvil head and shaft are brought close together, after thesurgeon has manually rotated the dial another thirty times, a grip-styletrigger 44 in the handle is manually actuated. This actuation causes acircular blade 46 to advance axially out from the tip of the shaft, andinto contact with the opposing face 48 of the anvil 36. The blade cutsthrough the stapled-closed ends of the proximal and distal ends of thecolon, thereby also cutting a new pair of ends of the proximal anddistal portions of the colon. The tissue which has been severed is heldin an interior volume at the end of the shaft.

In lock step with the cutting, the freshly opened ends are joinedtogether by a series of staples 50 which are advanced through holes inthe perimeter of the tip of the shaft (being pressed against and closedby the opposing face of the anvil). The coupled shaft and anvil are thenwithdrawn from the patient.

As with many such devices of the prior art, all of these devices areconsidered fully disposable, and are, in fact, thrown away after asingle use. They are complicated devices, having multiple moving parts,requiring substantial structural integrity and, therefore, expense inmanufacturing. The fact that they are used only once, and that no partcan be used again, render the use of such devices expensive and wastefulof resources.

In addition to this failure, as can be readily observed from thepreceding descriptions, the prior art devices suffer from numerous otherlimitations which would be desirable to overcome. These include therigid and limited length shaft of the anastomosing and staplinginstrument (which limits the portion of the gastrointestinal tract whichmay be treated by such a device), as well as the requirement that thesurgeon manually actuate a number of different functions (includingthose associated with the dial and trigger of the anastomosing andstapling instrument and the multiple triggers of the cutting andstapling instrument).

Therefore, it has been a principal object of recent inventions toprovide an instrument for cutting, anastomosing, and stapling, for usein gastrointestinal surgery, which reduces the waste of resources bypermitting the reuse of portions thereof, can extend farther into thecolon, and which are more simple to manipulate.

A substantial advance in the field of colon surgery has been disclosedin U.S. patent application Ser. No. 09/324,452, entitled “AnElectromechanical Driver Device for use with Anastomosing, Stapling, andResecting Instruments” which was invented by the same inventor as thepresent application, was assigned to the same assignee as the presentinvention, and the specification of which is hereby incorporated fullyby reference.

In particular, this prior invention, made by the present inventorcomprises an electromechanical driver assembly, mounted in ahandle-shaped base unit, which couples to and motivates remote surgicalattachments through a flexible shaft which may also be remotelymanipulated by means of a series of steering wires which are controlledwithin the handle as well.

First, with respect to the handle component and the flexible shaft. Thehandle has a pistol grip-styled design, having one or more, andpreferably two, finger triggers which are independently coupled to atleast one, and preferably two separate motors which each turn separateflexible drive shafts (described more fully, hereinbelow). The motorsare each dual direction motors, and are coupled to a manual drive switchmounted to the top of the handle, by which the user can selectivelyalter the turning direction of each motor. In addition to the motorcomponents, the handle further includes several other features,including: (1) an remote status indicator; (2) a shaft steering means;and (3) at least one additional electrical supply.

The flexible shaft comprises a tubular sheath, preferably formed of asimple elastomeric material which is tissue compatible and which issterilizable (i.e., is sufficiently rugged to withstand an autoclave).Within the elastomeric sheath are a pair of smaller fixed tubes whicheach contain a flexible drive shaft which is capable of rotating withinthe tube. The flexible drive shaft, itself, simply must be capable oftranslating a torque from the motor in the handle to the distal end ofthe shaft, while still being flexible enough to be bent, angled, curved,etc. as the surgeon deems necessary to “snake” through the colon of thepatient. As suggested above, in conjunction with the manuallyactuateable steering means mounted to the handle, the sheath furtherincludes at least two sets of steering wires which are flexible, but arecoupled to the inner surface of the sheath near the distal end thereof.The steering wires may be axially translated relative to one another byactuation of the steering means, which action causes the sheath to bendand curve accordingly.

Referring now to one possible surgical instrument attachment which wasdisclosed as a preferred embodiment in the above referenced co-pendingapplication entitled “An Electromechanical Driver Device for use withAnastomosing, Stapling, and Resecting Instruments”, the anastomosing andstapling attachment, this attachment comprises an anvil portion, and astaple, blade and reservoir portion, which includes a pair of turningdrive shafts which are coupleable to the drive components of the shaftelement described above, and a corresponding pair of advancing andretracting nuts mounted to the turning drive shafts, but which areprevented from rotating and therefore linearly advance and retract alongthe shafts when they turn.

The anvil portion is bullet shaped, having a blunt nosed top portion, aflat cutting support surface on the bottom, and a freely rotatingcoupling post extending axially from the bottom surface. This couplingpost is designed to be selectively coupleable and removable from thecorresponding nut mounted to one of the turning drive shafts.

The staple, blade, and reservoir portion (SBR portion) is cylindrical inshape, forming a housing which has a hollow interior. It is this hollowinterior which forms the reservoir. On the axially outward facingsurface of the cylindrical wall of the housing are a series of stapleports, through which the staples of the device are discharged. A seriesof staple drivers are mounted within the cylindrical walls, beneath thestaple ports, for driving the staples therethrough. The blade issimilarly cylindrical, and seats in the inside of the housing, againstthe inner surface of the wall thereof. Both the blade and the stapledriver are mounted to the second nut, which is, in turn, mounted to theother turning drive shaft. As the tuning drive shaft rotates, the nut(which is constrained against rotating) advances along the shaft, thuslinearly advancing the blade and staple driver. The blade and the stapledriver are, therefore, selectively advanceable axially outward from thehousing, in accordance with actuation of the appropriate trigger on thehandle.

In a preferred embodiment set forth in the referenced application, theanvil portion and the SBR portion further comprise an electromagneticsensor mechanism, coupled to the LCD indicator of the handle, whichsensor is activated when the two portions have approached each other tothe extent necessary for a safe staple firing, whereby the surgeon mayhave remote knowledge of the state of the attachment disposed within thecolon.

An observed problem with prior art devices used in the anastomosing,stapling and resecting surgical procedure described above, relates tothe best indications which the surgeon may remotely receive as to theconditions within the patients colon. For example, it is critical thatthe surgeon know whether the tissue being coupled forms a contiguous andsealed ring, such that the recoupled ends of the colon do not contain ahole through which bowel contents may leak into the body cavity. Postsurgical infection rates due to such failures are a leading cause ofcomplications and are often severe and are a leading cause of morbidity.

An associated issue of which surgeons who carry out these proceduresmust be cognizant relates to the ongoing viability of the tissue whichhas been resealed. A frequent post-surgical problem relates to thetissue necrosis which may occur if the staple ring is too tightlycompressing the tissue, and preventing necessary blood flow thereto. Asimple light-based mechanically measured distance indicator means isinsufficient to avoid both of these problem. Prior art devices fail toprovide the means by which information regarding the state of the tissuebeing manipulated may be measured and used by the surgeon, and theinstrument itself, to ensure a more positive outcome.

It shall be understood that this problem, i.e., the failure of remotelycontrolled surgical instruments to provide for the gathering,displaying, and influencing of automatic actions, of informationcritical to the success of the surgical procedure simultaneously withthe action of the device, is not limited to the specific instancesdiscussed above. Rather, this failure is prevalent throughout surgicalinstrumentation.

It is therefore a principle object of the present invention to provide asurgical attachment which is remotely controlled and includesinformation-gathering sensors, communication and processing capacities,information storage capacity, and indicating means by which the userand/or remote decision-making systems may choose to control theinstrument and activate the features of the attachment in accordancewith the gathered and relayed information.

Other objects of the present invention shall be recognized in accordancewith the description thereof provided hereinbelow, and in the DetailedDescription of Preferred Embodiments in conjunction with the remainingFigures.

SUMMARY OF THE INVENTION

The preceding objects of the invention are provided by anelectromechanical driver, a flexible shaft, and remote surgicalattachment including a controller processor unit mounted in the handlewhich is connected via cabling in the flexible shaft to a sensor andmemory unit in the remote attachment. More particularly, with respect tothe bowel surgery anastomosing, resecting, and stapling attachmentdescribed above in the Description of the Prior Art, the presentinvention shall be set forth with respect to the same application.Specifically, with respect to the sensor and memory unit mounted in theanastomosing, resecting, and stapling attachment, the sensor utilized isa pulse oximeter.

First, as described above, the present invention is preferably embodiedas a subsystem of a device which comprises three components, which are(1) an electromechanical driver, (2) a flexible shaft, and (3) ananastomosing, resecting, and stapling attachment.

First, with regard to the electromechanical driver, the handle has apistol grip styled design, having at least two finger-actuatabletriggers which independently initiate motors which turn drive shaftsmounted within the flexible shaft. The handle further includes a remotestatus indicator coupled to the processor unit in the handle. Thisindicator provides either visual, audio, or electrical output (to beoutput to a separate display device). The handle and flexible shaftfurther include a shaft steering means comprised of steering wirescontrolled by a handle mounted motor drive system including a manuallyactuatable steering means for directing the steering means, for example,a joystick or trackball, described more fully in co-pending applicationU.S. Ser. No. 09/510,923, now issued as U.S. Pat. No. 6,517,565,entitled “A Carriage Assembly for Controlling a Steering Wire SteeringMechanism within a Flexible Shaft”, which has been assigned to the sameassignee as the present invention, and which is incorporated hereinfully by reference.

In this embodiment of the electromechanical driver, the drivercomponents are integrated with the controller components. It should benoted that other embodiments of the electromechanical driver maycomprise a driver unit which is physically separate from a controllerunit. That is, the driver unit may comprise the above-described motorsand the above-described steering means, and the controller unit maycomprise the above-described triggers, the above-described remote statusindicator, as well as the above-described manually actuatable steeringmeans. The controller unit components communicate with the driver unitcomponents by wireless transmission, for example, through infrared,radio waves, other electromagnetic waves, or ultrasound. In such aconfiguration, for example, the driver unit may be located out of thesurgeon's arm's reach, while the controller unit may be selectivelycoupleable to that portion of the flexible shaft which is closer to thepatient and closer to the surgeon. It should be further understood thatadditional embodiments of the electromechanical driver assembly maycomprise more than two separate units, and such units may each houseonly one, or more than one, of the above-described separate components,all communicating by wireless means as described above. For example, theremote status indicator described above could be part of a third unitwhich mounts to a visor wearable by the surgeon. It should be furtherunderstood that all communications between these components as describedherein may in such alternative embodiments take place by wireless means.

Second, with respect to the flexible shaft, the shaft comprises atubular sheath, preferably formed of a simple elastomeric material whichis tissue compatible and which is sterilizable (i.e., is sufficientlyrugged to withstand an autoclave). Within the elastomeric sheath are apair of smaller fixed tubes, each of which contain a flexible driveshaft which is capable of rotating within the tube. As suggested above,in conjunction with the steering means mounted in the handle, the sheathfurther includes at least two steering wires which are flexible, but arecoupled to the inner surface of the sheath near the distal end thereof.In addition, the flexible shaft includes a least one electrical lead andcorresponding coupling terminals at each end, for coupling to theprocessor and controller means in the handle with the sensor and memorycomponents in the distally mounted surgical attachment.

Third, with regard to the anastomosing, resecting, and staplingattachment, a single example of the many alternative surgicalattachments which may include aspects of the present invention is nowdescribed. This attachment comprises a selectively advanceable andretractable anvil portion, and a staple, blade, sensor, and reservoirportion. This latter element includes the drive elements necessary tomove the anvil forward and back, as well as the motive elements whichdrive the staples and blade through the tissue. These motive elementsare coupleable to the drive components of the shaft element describedabove. Included in the staple, blade, sensor and reservoir portion,also, are a pulse oximeter sensor and a tissue proximity sensor, as wellas a memory unit which contains important identification informationwhich may be retrieved by the processor unit in the handle uponconnection to the flexible shaft.

As stated above, when initially coupled to the flexible shaft (whichshall be hereinafter taken to be permanently coupled to the handleunit), and the handle is powered up, the first internal act to takeplace is for the processor unit in the handle to query the memory unitin the attachment as to its identity and status. More particularly, asthe anastomosing, resecting, and stapling attachments may come indifferent diameters, shapes, lengths, and stapling arrangement (as wellas many other potential variations) which are readily readable by thehandle mounted processor unit and displayed for the user either on aremote display panel to which the handle is coupled, or on a displayscreen which is integrally included in the handle itself.

The status of the attachment shall also be queried, for example, as towhat the functionality of the attachment is, and whether or not it hasbeen previously used, and therefore, no longer capable of firing asecond time.

Once this information has been gathered, and it is determined that theattachment is the appropriate one, the surgical step for which thisattachment is utilized may continue. In particular, the anvil tip isadvanced via action of the drive motor and drive elements of the handle,shaft, and attachment, until it may be manually separated from theremainder of the attachment. The appropriate opening is made in thepreviously cut and stapled closed proximal end of the bowel and theanvil tip of the attachment is placed therein. The remainder of theattachment and the appropriate length of the flexible shaft is insertedthrough the rectum and up the bowel until the attachment coupling shaftis advanced through a small opening in the cut and stapled closed distalend of the bowel section.

After recoupling, the anvil portion is retracted toward the staplingportion until it is mechanically determined that the two portions arewithin the range which is appropriate for staple firing. At this time,the physician user is unable to simply remotely fire the staples. Thislock out feature is maintained by the processor unit until such time asthe surgeon causes the processor until in the handle to query the tissueproximity sensor and the pulse oximeter sensor in the attachment todetermine if the tissues to be stapled together form a completelycontiguous ring so that the two tubular sections of bowel can beproperly mechanically united. This measurement may be made optically, orby any other suitable means, by which the transmission of some signalwhich should be blocked by the intervening tissue is received by anopposing sensor. The results of this query are then relayed back to theprocessor in the handle which carries out the appropriate analysis. Ifthe proximity query results in a negative analysis outcome, an indicatorlight, audible alarm, or other suitable means of alerting the surgeon tothis condition is provided. The processor will also disarm the staplingmechanism (by removing power to the drive mechanisms, for example) toprevent an attempted override by the surgeon.

If the proximity query results in a positive response, however, the nextin the series of tests to determine if the surgeon may safely join thesections of bowel is carried out. Specifically, the processor in thehandle activates the pulse oximeter sensor and queries it regardingwhether the proper level of blood profusion remain in the tissuesections to be joined. As suggested above, if the stapling procedure hasthe effect of cutting off the necessary blood supply to sections of thejoined tissue, a necrotic region will develop in the bowel, and futurecomplications (which may be fatal) will arise. The results of this queryare also relayed to the processor in the handle. Again, if the resultsof the processing of this information is negative, an indication of thisstate is provided by the processor. As above, if negative, the surgeonwill be unable to mechanically fire the staples, as the processor willdisarm the motor assembly.

Additional features and aspects of the present invention are set forthin greater detail in the description of the preferred embodimentsprovided hereinbelow.

A BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side perspective view of an anastomosing, resecting, andstapling instrument of the prior art;

FIG. 2 is a side cross-section view of a handle and flexible shaft ofthe present invention, wherein important internal features of thecontrol systems are provided in detail;

FIG. 3 is a side cut-away view of an anastomosing, resecting, sensing,and stapling attachment which is also an aspect of the presentinvention; and

FIG. 4 is a flow chart illustrating the logical sequence of processor,sensor, and mechanical actions which are illustrative of features of thepresent invention.

A DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

While the present invention will be described more fully hereinafterwith reference to the accompanying drawings, in which particularembodiments are shown, and with respect to methods of surgical use, itis to be understood at the outset that persons skilled in the art maymodify the invention herein described while achieving the functions andresults of this invention. Accordingly, the descriptions which followare to be understood as illustrative and exemplary of specificstructures, aspects and features within the broad scope of the presentinvention and not as limiting of such broad scope. Like numbers refer tosimilar features of like elements throughout.

Referring now to FIG. 2, with respect to the electromechanical driver100, the driver has a handle portion 102 and a flexible drive shaftportion 104. The handle 102 includes a portion which is shaped in amanner which is easily gripped by the surgeon operator, for example, inthe embodiment provided herein the handle comprises a pistol grip-styledportion 106. The grip portion 106 includes at least two, and in thepresent embodiment exactly two, independently finger-actuateabletriggers 108 a,108 b. The finger triggers 108 a,108 b are independentlycoupled to separate motors 110,112, housed within the interior volume ofthe handle 100. Each motor 110,112 turns a separate flexible drive shaft(described more fully, hereinbelow).

More particularly, with respect to the motors 110,112, each is a dualdirection motor. In addition to being coupled to the finger-actuateableswitch, the motors are also each separately coupled to a power source114 (which is a common source in the present embodiment) and a manualdrive switch 116. The manual drive switch 116 is provided on the top ofthe handle 100, such that the surgeon operator can selectively alter theturning direction of each motor. In the preferred embodiment, the powersource 114 supplying the motors 110,112 is a single direct currentsupplying removable and rechargeable battery pack. It shall beunderstood that alternative power sources, including dual direct currentsources or single remote alternating current sources (such as thealternating current provided from standard United States 120 Volt, 60Hertz wall outlets) may be used in conjunction with alternativeembodiments. In the event that the driver device should be useable withan alternating current, either a transformer can be included between themotor and the power source, or a more sophisticated intermediate gearingassembly may be provided between the motor and the extended turningdrive shaft.

In addition to the motors 110,112 components and the related power anddrive switch elements, the handle 100 further includes a motor drivenshaft steering carriage assembly, which is coupled to a manual inputmeans, which is coupled to steering wires in the flexible shaft forselectively steering the distal tip of the flexible drive shaft 122.

The handle also includes a processor element 140 and output displaydevice 142 (mounted on the exterior of the handle). The processorelement 140 and the display device 142 are each electrically coupled tothe power source to provide electrical power to carry out their actions.The processor unit and display element are similarly coupled to oneanother to permit the processor to display the signal output generatedthereby. The processor unit is also coupled via an electrical cable 144to an input terminal 146 at the distal tip of the flexible shaft 122.

More particularly, with respect to the flexible shaft 122, the shaftcomprises a tubular sheath 128 which is formed of a simple, tissuecompatible, elastomeric material. As this device is to be reused, it isimportant that the material be sterilizable (i.e., is sufficientlyrugged to withstand an autoclave). While the embodiment illustratedcomprises a contiguous handle 100 and shaft 122, it shall be understoodthat one having ordinary skill in the art may provide an alternativeembodiment having a separable handle and shaft, thus permittingalternative shaft lengths for alternative purposes. In such cases, theflexible shaft 122 and the handle 100 portions should include aninterface between the proximal end of the shaft and the distal end ofthe handle which should include a coupling means for the drivecomponents.

Specifically regarding the drive components 130 a,130 b of the shaft122, within the elastomeric sheath 128 are a pair of smaller fixed tubes134 a,134 b which each contain a flexible drive shaft 136 a,136 b whichis capable of rotating within the corresponding tube 134 a,134 b. Theflexible drive shaft 122, itself, simply must be capable of translatinga torque from the motor in the handle to the distal end 138 a,138 b ofthe shaft 122, while still being flexible enough to be bent, angled,curved, etc. as the surgeon deems necessary to “snake” through the colonof the patient. For example, the drive shafts may comprise a woven steelfiber cable, a high tensile strength polymeric material, or asufficiently flexible unitary metal shaft.

In order for the distal ends 138 a,138 b of the drive shafts 136 a,136 bto couple with an attachment, such as anastomosing, resecting, sensing,and stapling attachment, the distal tips 138 a,138 b of the drive shaftsmust have a conformation which permits the continued translation oftorque. In the present embodiment, this coupling is achieved by ageometric fitting, and more precisely, the distal tips of the driveshafts are hexagonal, and thereby fit into a hexagonal recesses in thecoupling interface of the attachment. In a preferred embodiment, theattachment and the distal end of the shaft should include a collar, orother aligning means, for facilitating the fitting of the attachmentonto the distal end of the shaft.

In addition, the shaft includes an electrical wire 144 extending fromthe end coupled to the handle to the end which couples to the surgicalattachment. The first end of the shaft includes the terminal inputswhich are coupled to the processor unit. The second end includes aterminal 146 for coupling to the corresponding electrical input/outputof the surgical attachment (described more fully hereinbelow).

With reference now to FIG. 3, a preferred embodiment of the anastomosingand stapling attachment 200 is described. This attachment comprises ananvil portion 202, and a staple, blade, sensor, and reservoir (SBSR)portion 204, which includes a pair of turning drive shafts 206 a,206 bwhich are coupleable to the drive components 136 a,136 b of the drivercomponent described above with reference to FIG. 2, and a correspondingpair of advancing and retracting members 208 a,208 b mounted withintracks and to the turning drive shafts, which are thereby prevented fromrotating and therefore linearly advance and retract along the shafts 206a,206 b when they turn. The anvil portion includes a series of lightdetectors. The SBSR includes pulse oximeter and tissue proximity sensors150, 152 and a memory and signal transmitter and receiver member 154which couples to the flexible shaft at the corresponding terminalthereon by way of an electrical coupler 158 shown.

The anvil portion 202 is bullet shaped, having a blunt nosed top portion210, a flat cutting support surface 212 on the bottom, and a couplingpost 214 extending axially from the bottom surface. This coupling post214 mounts to the first advancing and retracting member 208 a which ismounted within a linear track whereby rotation of the shaft 206 a causesthe member 208 a and the anvil 202 coupled thereto to move axially, butnot rotationally. The exterior surface of the face of the anvil whichopposes the SBSR includes a series of light emitting diodes 154.

The staple, blade, sensor, and reservoir portion (SBSR) portion 204 iscylindrical in shape, forming a housing which has a hollow interior 216.It is this hollow interior which forms the reservoir. On the axiallyoutward facing surface 218 of the cylindrical wall 220 of the housingare a series of staple ports, through which the staples 224 of thedevice are discharged. A unitary blade and cylindrical staple drivercomponent 226 is seated within the housing. A circumferential pulseoximeter 150 is mounted in the housing on the outside rim of thehousing, radially adjacent to the staple ports. A pulse oximeter is asimple device which shines a specific frequency of light through asection of tissue to measure the absorption rate of the light. Becauseoxygenated blood has a different color than does blood which is notfully oxygenated, the profusion of fresh blood through a tissue may bedetermined by this device. Therefore, the pulse oximeter comprises aseries of light emitting elements 154 on the anvil and light sensors 150mounted around the circumferential rim of the housing member. As shown,the components of the pulse oximeter are electrically connected viawires running through the coupling post of the anvil.

In addition, the attachment also includes a tissue proximity sensor 152,a portion of which is similarly mounted to the external rim of thehousing, radially adjacent to the pulse oximeter 150 and the stapleports. In addition, the tissue proximity detector 152 comprises a seriesof simple light emitting elements 154 on the anvil (for example the samelight emitting elements of the pulse oximeter), and a correspondingseries of light detectors 152 mounted around the circumferential rim ofthe housing member. In the proximity sensor, if the tissue which issupposed to be disposed between the anvil and housing is present, thenthe proximity sensor's light detectors will not receive a signal (or atleast below a set threshold), alternatively, if the tissue is missing,then the light detectors will receive a stronger signal, indicating thatthere is no tissue blocking the transmission of the light.

More particularly, the blade and staple driver component comprises asingle element having two concentric cylindrical portions. The bladeportion 228 seats within the hollow interior 216, against the interiorwall 230 thereof. The staple driver portion 232 seats within the wall230 of the SBSR portion and includes a series of outwardly projectingprotuberances which push against staples mounted within the stapleports.

The blade 228 and staple driver portions 232 are coupled at the interiorend thereof to a threaded member 208 b which seats around turning shaft206 b. The threaded member 208 b is constrained within a linear track sothat the blade and staple driver are advanced linearly upon rotation ofthe turning shaft 206 b.

In practice and with reference to the flow chart provided in FIG. 4,this attachment and the associated controller features of the presentinvention are utilized once the section of the colon to be removed hasbeen resected and the two opposing ends of the adjacent bowel have beenstapled shut. The surgeon begins by coupling the anastomosing,resecting, sensing, and stapling attachment 200 to the distal end of theflexible shaft. The processor in the handle unit queries the memoryelement in the attachment and requests identification information. Theattachment transmits the requested information, including size, statusand functionality information. The processor in the handle outputs thisinformation to the display panel, for visual inspection by the surgeonuser. The processor further establishes whether the surgeon may activatethe driver means in correspondence to whether the information receivedfrom the attachment was acceptable (i.e., is it unused and functional).

In the event that the identification information received is acceptable,the surgeon then triggers the electromechanical driver to advance theanvil portion 202 to its fullest extent. The anvil head 202 is thendecoupled from the first advancing and retracting member 208 andinserted into the stapled proximal end of the bowel (which is thenopened partially to receive the anvil head). The proximal end of thebowel is then sutured closed. The surgeon then advances the shaft 206 aand the SBSR portion 204 of the attachment up the colon until it extendsthrough the stapled distal end of the colon. (Alternatively, the surgeonmay advance only the flexible shaft up the colon and then reattach theSBSR portion to the distal end once it emerges from the distal end ofthe bowel.) The surgeon then couples the anvil 202 to the advancing andretracting member 208 a by rotation of the corresponding drive shaft 136a. Subsequent reverse biasing and triggering of the same motor in thehandle 100 causes the anvil 202 to retract toward the SBSR portion 204.

Once retracted into the safe staple firing range, the processor disablesthe staple firing motor and again queries the attachment. In fact, theprocessor in the handle transmits an activation signal to the pulseoximeter, to sense the blood profusion through the tissue compressedbetween the anvil and SBSR portions. If the response received from thesensor is that the blood flow through the tissue has been compromised,the anvil portion is repositioned and the process begins anew. If theresponse received from the sensor is that the blood flow is acceptable,then the processor activates the tissue proximity sensor. If theresponse is that the tissue is properly situated, then the staple driveris armed and the surgeon can fire the staples at will by manipulatingthe trigger on the handle. If the proximity detector response isnegative, the anvil is repositioned.

While there has been described and illustrated new and novelelectromagnetic driver mechanisms having an attachment processorcontroller, for use with surgical attachments, it will be apparent tothose skilled in the art that variations and modifications are possiblewithout deviating from the broad spirit and principle of the presentinvention which shall be limited solely by the scope of the claimsappended hereto.

1-26. (canceled)
 27. A medical device, comprising: an electromechanicaldriver; an elongate shaft having drive elements actuatable by theelectromechanical driver; a surgical stapling attachment coupleable tothe drive elements of the shaft, the surgical stapling attachmentincluding a stapling portion, a blade, and an anvil; and at least onesensor in the surgical stapling attachment, the at least one sensorbeing arranged to confirm that the tissue to be stapled together form acontiguous ring of tissue disposed between the stapling portion and theanvil.
 28. The medical device of claim 27, wherein the at least onesensor includes a pulse oximetry sensor.
 29. The medical device of claim27, wherein the shaft has a distal end configured to couple withsurgical stapling attachments having one or more of different diameters,shapes, lengths and stapling arrangements.
 30. The medical device ofclaim 27, wherein the stapling portion has a circular shape.
 31. Themedical device of claim 27, further comprising a remote statusindicator.
 32. The medical device of claim 27, further comprising acontroller having a processor and a memory unit.
 33. The medical deviceof claim 32, wherein the controller and electromechanical driver areintegral components.
 34. The medical device of claim 27, wherein theelectromechanical driver has two motors.
 35. The medical device of claim34, wherein the electromechanical driver has two shafts.
 36. The medicaldevice of claim 27, further comprising an output display device.
 37. Themedical device of claim 27, wherein the electromechanical driver isdisposed in a handle.
 38. The medical device of claim 37, wherein theelongate shaft is removably attached to the handle.
 39. The medicaldevice of claim 27, wherein the at least one sensor includes a lightdetecting element.
 40. The medical device of claim 27, wherein the shaftis flexible.
 41. The medical device of claim 27, wherein the shaft issteerable.
 42. The medical device of claim 41, further comprisingsteering wires for steering the shaft.
 43. The medical device of claim27, wherein at least one of the drive elements rotate.
 44. The medicaldevice of claim 43, wherein the surgical stapling attachment includes anut, the blade and a staple driver being attached to the nut.
 45. Themedical device of claim 44, wherein the nut is mounted on the rotatabledrive elements.
 46. The medical device of claim 27, further comprising amemory unit disposed in the surgical stapling attachment.
 47. Themedical device of claim 27, further comprising a controller thatcommunicates wirelessly.
 48. A medical device, comprising: anelectromechanical driver; an elongate shaft having drive elementsactuatable by the electromechanical driver; a surgical staplingattachment coupleable to the drive elements of the shaft, the surgicalstapling attachment including a stapling portion, a blade, and an anvil;and a plurality of sensors around the circumferential rim of thestapling portion, the sensors being arranged to confirm that the tissueto be stapled together is disposed between the stapling portion and theanvil.
 49. A medical device, comprising: an electromechanical driver; anelongate shaft having drive elements actuatable by the electromechanicaldriver; a surgical stapling attachment coupleable to the drive elementsof the shaft, the surgical stapling attachment including a staplingportion, a blade, and an anvil; at least one sensor in the surgicalstapling attachment, the at least one sensor being arranged to determinea distance between the stapling portion and the anvil; and a controllercomponent arranged to interact with the at least one sensor and todetermine the distance between the stapling portion and the anvil.